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Quality Assurance Supervisor (Compliance)
Location: Alva, Clackmannanshire - FK12 5DQ
Salary: £42,138 - £50,767 per annum DOE plus benefits
Contract: Permanent, Full time
AccuBio Ltd. (manufacturers of In vitro Medical Devices) are currently recruiting for a Quality Assurance Supervisor (Compliance)
Job Purpose:
As our Quality Assurance Supervisor, your overall job purpose is to lead the development and implementation of the site Quality Strategy that is compliant with all relevant quality bodies, standards and directives and contributes to the overall delivery of the UK vision and strategic objectives.
You will plan and coordinate organisation's activities required to meet quality standards and compliance to industry standards.
Responsibilities:
Main Areas:
Lead the development and implementation of the site quality strategy that is compliant with all relevant external standards and directives
Fulfil the requirements of the site Quality Management Representative and person responsible for Regulatory Compliance (PRRC) role
Maintain current knowledge of IVDD/R industry developments, and relevant quality bodies, standards, and directives; make recommendations regarding any changing requirements to the President
Lead, plan and manage the site audit programme (internal and external) to meet the required standards and schedules
Lead, plan and manage the site quality training programme to meet the requirements of the site quality system and audit programme
Create a positive working environment in the quality department that facilities employee engagement and a culture of high performance and continuous improvement
Monitor quality department KPI's and implement strategies and processes as required to meet agreed targets
Plan and manage all quality department expenditure within agreed budgets
Collaborate with R&D department regarding new product development and with commercial and operations teams regarding customer requirements
Develop and maintain productive and professional relationships with colleagues, customers, and other third parties
Contribute to the development and implementation of the site and vision strategic objectives, plans and strategic projects in conjunction with the
Senior Management Team
Maintain the company's quality requirements from external suppliers
Work with supply chain to maintain quality requirements from external suppliers
Maintain the quality management system via controlling documentation and records
Monitor the progress of corrective and preventive action activities and the handling of nonconforming product
Assess the effectiveness of changes made to quality management system
Make sure the company is working as effectively to be cGMP and other quality related standards e.g., ISO 13485 compliant
Ensure effective management of customer complaint handling, vigilance reporting and management of field actions,
Risk management process owner
Post marketing surveillance - plan and manage PMS & PMPF activities
People Management Areas of Responsibility:
Lead by example and demonstrate consistent, good HR practice and people management
Motivate direct reports to achieve their potential through PDR's regular 1:1's and training or development
General Areas of Responsibility:
Carry out all duties and responsibilities to the company standard within the timescales required.
Maintain compliance with Health & Safety policies and procedures.
Maintain compliance with QMS policies and procedures.
Maintain compliance with GDPR and Cyber Security policies and procedures.
Perform any other reasonable duties and responsibilities as required
Knowledge, Skills & Experience:
Essential:
Life Science Degree
Minimum 5 years' experience in Quality Assurance function for medical device or In-vitro device manufacturer
Understanding of Medical Device (MDR) and/or IVD Regulation (IVDR) and associated ISO standards
Good understanding of core IT packages, especially Microsoft Excel, Visio and Adobe Acrobat EQMS
Excellent written English
Ability to motivate and develop staff and lead by example
Highly motivated, energetic
Ability to work under pressure and meet deadlines
Great attention to detail with good report writing skills
Clear communication in spoken and written form
Effective time management and prioritisation skills
Able to establish working relationships at all levels
Desirable:
Internal and Lead Auditor Risk management
Supervisory experience within a Quality Assurance function, in a medical device or similarly regulated industry
Q-Pulse
About us:
AccuBio is a UK based company (2022), wholly owned by Zhejiang Orient Gene Biotech, who were formed in 2005. Our company vision is to become a great enterprise in the field of global in-vitro diagnostics, that integrates global science and technology to provide health diagnosis and support for life.
Core values:
Continuous Innovation
Customer Orientation
Challenge the Impossible
Grow Together
Due to the volume of applications, we are unable to respond to all applications. If you do not hear from us in four weeks please assume that your application has been unsuccessful.
If you feel you have the necessary skills and experience to be successful in this role click on APPLY today, forwarding an up to date copy of your CV for consideration in the first instance.
No agencies please.
